Weight management systems and related methods

ABSTRACT

Systems and methods of weight management and compositions or formulations useful therein are disclosed and described.

PRIORITY DATA

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/873,048, filed Sep. 3, 2014, which isincorporated herein by reference.

BACKGROUND

Excessive body weight is becoming a concern around the world, forexample, over half of the American adult population is considered to beoverweight or obese. Being overweight is associated with severalconditions or chronic diseases such as hypertension, elevatedcholesterol, type 2 diabetes, stroke, osteoarthritis, and sleep apnea.Economically, the annual costs for excessive body weight on medicalexpenses and lost income is approximately 70 billion dollars, in theUnited States alone.

There are many factors that affect body weight or influence a person'sability to lose weight. Many diet programs focus solely on energy(kcals) intake yet the body responds differently to macronutrients (i.e.with simple carbohydrates, the insulin response triggers the body tostore fat). Furthermore as dietary energy levels decrease, the bodymeets its energy demands through utilizing protein and lean body tissueas its primary energy source. Therefore, as a person loses weight therecan be a significant loss of muscle which can adversely affect bodyweight maintenance over the long term. Moreover, if the dieter ceasesthe diet and gains back some or all of the weight lost, it willtypically be as fat. Thus, the dieter may find themselves in an evenworse physical condition than when they started the diet as they nowweigh the same as before, but have a higher percentage of body fat andlower percentage of muscle.

SUMMARY OF THE INVENTION

A goal for weight management or maintenance should be preservation oflean tissue and utilization of fat stores. With this in mind, dietaryprotein provides an essential branched chain amino acid, leucine tosignal and regulate several processes in the muscle. Interestingly, themajority of dietary protein is consumed primarily at the evening mealwhich means that throughout the day the body does not have adequatelevels of leucine. Furthermore, the typical American consumes mainlycarbohydrates for breakfast and lunch signaling the body to store fat.

A number of natural ingredients can assist with the body's ability toburn fat as well as maintain lean body mass (muscle). Furthermore, it isnot practical for setting a specific energy dietary level for every bodyshape and size. As such, important aspects of the present inventioninclude formulations, systems, programs, regimens, and methods whichprovide weight loss to a subject while minimizing loss of lean muscletissue. In other words, that majority of weight that is lost is fat. Onecomponent of this may be administering formulations that aid the subjectwith weight loss by for example, stimulating metabolism and energy,reducing hunger signals and food cravings, regulating certain hormones,and providing a sense of wellness, or wellbeing, including mental andemotional wellbeing. Another component can be administration ofsufficient amounts of protein at certain times in order to benefit ofthe physical aspects of protein consumption (e.g. leucine production,etc.).

In one embodiment, a weight loss system is provided. Such a system cancomprise a weight loss accelerator formulation that accelerates weightloss in a subject beginning to utilize the system, a weight lossstimulator formulation that stimulates weight loss in a subjectbeginning to utilize the system and continues stimulating weight losswith ongoing consumption after completing use of the weight lossaccelerator, and a weight loss control formulation that aids a subjectin controlling appetite and calorie consumption when said subject isbeginning and continuing to utilize the system.

In one embodiment, the weight loss accelerator formulation isadministered at least once daily for up to 30 days from the time a userbegins using the system. In another embodiment, the weight lossaccelerator formulation is administered once daily for a duration of 15days from the time a user begins using the system.

In one embodiment, the weight loss accelerator is administered as abeverage. In another embodiment, the beverage is prepared from a powder.

In one embodiment, the weight loss accelerator formulation provides adosage comprising from about 1000 mg to about 3000 mg opuntiaficus-indicia (prickly pear) fruit powder; from about 100 mg to about200 mg crocus sativus L. stigma (saffron) fruit powder extract; fromabout 100 mg to about 200 mg punica granatum (pomegranate) fruitextract; and from about 100 to about 200 mg of citrus sinensis (bloodorange) fruit extract. In another embodiment, the amount of opuntiaficus-indicia is about 2000 mg; the amount of crocus sativus L. stigmais about 177 mg; the amount of punica granatum is about 150 mg; and theamount of citrus sinensis is about 125 mg.

In one embodiment, the weight loss stimulator formulation isadministered at least once daily for up to 360 days from the time a userbegins using the system. In another embodiment, the weight lossstimulator formulation is administered daily for up to 90 days from thetime a user begins using the system. In a further embodiment, the weightloss stimulator formulation is administered to the subject within 30minutes of eating each meal. In yet a further embodiment, the weightloss stimulator formulation is in an oral dosage capsule form.

In one embodiment, the weight loss stimulator formulation provides adosage comprising a citrus sinensis (red orange) fruit extract in amountof from about 50 mg to about 250 mg; a undaria pinnatifida (brownseaweed) extract in an amount of from about 50 to about 250 mg; acamellia sinensis (green tea) leaf extract in an amount of about 30 toabout 150 mg; citrus bioflavonoids in an amount of from about 20 mg toabout 100 mg; quercetin (an allium cepa alliaceae (onion) bulb extract)in an amount of from about 10 mg to about 75 mg; and a capsicum annum L.(cayenne) fruit powder in an amount of from about 10 mg to about 52 mg.In another embodiment, the amount of citrus sinensis fruit extract isabout 83.3 mg; the amount of undaria pinnatifida extract is about 83.3mg; the amount of camellia sinensis leaf extract is about 50 mg; theamount of citrus bioflavonoids is about 33.3 mg; the amount of quercetinis about 25 mg; and the amount of capsicum annum L. fruit powder isabout 16.7 mg in an individual unit dosage.

In one embodiment, three individual unit dosage forms of weight losscontrol formulation are administered daily. In another embodiment, theweight loss control formulation is administered at least once daily forup to 360 days from the time a user begins using the system. In anotherembodiment, the weight loss control formulation is administered dailyfor up to 90 days from the time a user begins using the system.

In one embodiment, the weight loss control formulation provides a dosagecomprising a theobroma cacao (cocoa) bean powder extract in an amount offrom about 150 mg to about 1500 mg; a prunus cersus (tart cherry) fruitpowder extract in an amount of from about 75 mg to about 600 mg; apunica granatum (pomegranate) fruit extract in an amount of from about60 mg to about 500 mg; and a camellia sinensis (green tea) leaf extractwith added L-theanine in an amount of from about 100 mg to about 860 mg.In another embodiment, the amount of theobroma cacao extract is about187.5 mg; the amount of prunus cersus extract is about 75 mg; the amountof punica granatum extract is about 62.5 mg; and the amount of camelliasinensis extract is about 107.5 mg in an individual dosage unit.

In one embodiment, four individual unit dosage forms of weight losscontrol formulation are administered daily. In another embodiment, twoindividual unit dosage forms are administered prior to two meals. In yeta further embodiment, administration is within 30 minutes prior to themeals.

In one embodiment, the weight management system, program, regimen, ormethod can include a protein supplement that can be consumed by thesubject as needed to maintain a minimum daily protein intake. In anotherembodiment, the protein supplement provides at least 30 grams ofprotein.

In an additional embodiment, a weight loss system according to thepresent invention can comprise:

a weight loss accelerator formulation that accelerates weight loss in asubject beginning to utilize the system, said accelerator formulationproviding a dosage comprising about 2000 mg opuntia ficus-indicia(prickly pear) fruit powder, about 177 mg crocus sativus L. stigma(saffron) fruit powder extract, about 150 mg punica granatum(pomegranate) fruit extract, and about 125 mg of citrus sinensis (bloodorange) fruit extract;

a weight loss stimulator formulation that stimulates weight loss in asubject beginning to utilize the system and continues stimulating weightloss with ongoing consumption after completing use of the weight lossaccelerator, said stimulator formulation providing a dosage comprisingabout 83.3 mg of a citrus sinensis (red orange) fruit extract, about83.3 mg of a undaria pinnatifida (brown seaweed) extract, about 50 mg ofa camellia sinensis (green tea) leaf extract, about 33.3 mg of citrusbioflavonoids, about 25 mg of quercetin (an allium cepa alliaceae(onion) bulb extract), and about 16.7 mg capsicum annum L. (cayenne)fruit powder; and

a weight loss control formulation that aids a subject in controllingappetite and calorie consumption when said subject is beginning andcontinuing to utilize the system, said weight loss control formulationprovides a dosage comprising about 187.5 mg theobroma cacao (cocoa) beanpowder extract, about 75 mg of a prunus cersus (tart cherry) fruitpowder extract, about 62.5 mg of a punica granatum (pomegranate) fruitextract, and about 107.5 mg of a camellia sinensis (green tea) leafextract with added L-theanine

wherein one unit dosage of the weight loss accelerator formulation isadministered once daily for a duration of about 15 days from the timethat a user commences the program and three unit dosages of the weightloss stimulator are individually administered once daily for a durationof about 90 days from the time that a user commences the program, andtwo unit dosages of the weight loss control formulation are administeredtwice daily.

The weight management methods, systems, programs and regimens of thepresent invention additional encompass a weight loss regimen comprisingadministering a weight loss accelerator formulation to a subject at thebeginning of the regimen, administering a weight loss stimulatorformulation to the subject at the beginning of the regimen concurrentlywith the weight loss accelerator formulation and continuing aftercessation of the weight loss accelerator formulation, and administeringa weight loss control formulation to the subject concurrently with theweight loss stimulator formulation.

In one embodiment, a protein supplement can be administered to thesubject concurrently with all previously recited weight lossformulations in order to maintain a minimum daily protein intake.

In another embodiment, the weight loss accelerator is administered tothe subject for a period of 15 days at the beginning of the regimen. Ina further embodiment, the weight loss stimulator and controlformulations are administered to the subject for a period of 90 days.

In yet another embodiment, the regimen includes a dietary or eating planas further recited herein. In one embodiment, such an eating plandelivers 6 portions of protein, 2 portions of vegetables, 2 portions offruit, and 2 portions of complex carbohydrates per day. In an additionalembodiment, each portion has a size based on the subjects hand size andapproximately one handful equals approximately one portion.

In addition to the foregoing, the present invention encompasses methodsof managing, regulating, or controlling weight in a subject.Furthermore, in some embodiments, weight loss occurring employing suchmethods can minimize the loss of lean muscle tissue and maximize theloss of fat. In some embodiments, substantially no muscle tissue islost. Such a method can include any and all activities described orotherwise inferred herein, including engaging the subject in a weightloss regimen as discussed and/or administering the disclosed anddescribed weight loss systems to the subject.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 is a graphical representation of ingestion of 90 g of protein,distributed evenly over 3 meals (A) as compared to typical ingestion of90 g of proteins unevenly distributed throughout the day (B).Stimulating muscle protein synthesis to a maximal extent during themeals shown in (A) is more likely to provide a greater 24 h proteinanabolic response than an unequal protein distribution.

EXAMPLE EMBODIMENTS

Before the present invention embodiments are disclosed and described, itis to be understood that the invention embodiments are not limited tothe particular structures, process steps, or materials disclosed herein,but are extended to equivalents thereof as would be recognized by thoseordinarily skilled in the relevant arts. It should also be understoodthat terminology employed herein is used for the purpose of describingparticular embodiments only and is not intended to be limiting.

In describing and claiming the present invention, the followingterminology will be used.

The singular forms “a,” “an,” and “the” include plural referents unlessthe context clearly dictates otherwise. Thus, for example, reference to“a carrier” includes reference to one or more of such carriers, andreference to “an excipient” includes reference to one or more of suchexcipients.

As used herein, “formulation” and “composition” may be usedinterchangeably, and refer to a combination of two or more elements, orsubstances. In some embodiments a composition may include an activeagent in combination with a carrier or other excipients, adjuvants, etc.

As used herein, “effective amount” refers to an amount of an ingredientwhich, when included in a composition, is sufficient to achieve anintended compositional or physiological effect. Thus, a “therapeuticallyeffective amount” refers to a non-toxic, but sufficient amount of anactive agent, to achieve therapeutic results in treating or preventing acondition for which the active agent is known to be effective. Likewise,an “effective amount” of a formulation or composition is an amountsufficient to achieve a desired or intended physiologic effect. It isunderstood that various biological factors may affect the ability of asubstance or formulation to perform its intended task. Therefore, an“effective amount” or a “therapeutically effective amount” may bedependent in some instances on such biological factors. Further, whilethe achievement of therapeutic effects may be measured by a physician orother qualified medical personnel using evaluations known in the art, itis recognized that individual variation and response to treatments maymake the achievement of therapeutic effects a subjective decision. Thedetermination of an effective amount is well within the ordinary skillin the art of pharmaceutical sciences and medicine.

As used herein, “subject” refers to a mammal that may benefit from theadministration of a system, composition, program, routine, regimen,formulation, or method as recited herein. In one aspect, the subject canbe a mammal. In one aspect, the subject can be human.

As used herein, “administration,” and “administering” refer to themanner in which an agent, or composition containing such, is presentedto a subject. Administration can be accomplished by various routeswell-known in the art such as oral and non-oral methods.

As used herein, “oral administration” refers to a route ofadministration that can be achieved by swallowing, chewing, or suckingof an oral dosage form comprising the drug. Examples of well-known oraldosage forms include tablets, capsules, caplets, powders, granulates,beverages, syrups, elixirs, confections, or other food items, etc.

As used herein, “comprises,” “comprising,” “containing” and “having” andthe like can have the meaning ascribed to them in U.S. Patent law andcan mean “includes,” “including,” and the like, and are generallyinterpreted to be open ended terms. The terms “consisting of” or“consists of” are closed terms, and include only the components,structures, steps, or the like specifically listed in conjunction withsuch terms, as well as that which is in accordance with U.S. Patent law.“Consisting essentially of” or “consists essentially of” have themeaning generally ascribed to them by U.S. Patent law. In particular,such terms are generally closed terms, with the exception of allowinginclusion of additional items, materials, components, steps, orelements, that do not materially affect the basic and novelcharacteristics or function of the item(s) used in connection therewith.For example, trace elements present in a composition, but not affectingthe composition's nature or characteristics would be permissible ifpresent under the “consisting essentially of” language, even though notexpressly recited in a list of items following such terminology. Whenusing an open ended term, like “comprising” or “including,” it isunderstood that direct support should be afforded also to “consistingessentially of” language as well as “consisting of” language as ifstated explicitly and vice versa.

The terms “first,” “second,” “third,” “fourth,” and the like in thedescription and in the claims, if any, are used for distinguishingbetween similar elements and not necessarily for describing a particularsequential or chronological order. It is to be understood that any termsso used are interchangeable under appropriate circumstances such thatthe embodiments described herein are, for example, capable of operationin sequences other than those illustrated or otherwise described herein.Similarly, if a method is described herein as comprising a series ofsteps, the order of such steps as presented herein is not necessarilythe only order in which such steps may be performed, and certain of thestated steps may possibly be omitted and/or certain other steps notdescribed herein may possibly be added to the method.

Concentrations, amounts, solubilities, and other numerical data may bepresented herein in a range format. It is to be understood that suchrange format is used merely for convenience and brevity and should beinterpreted flexibly to include not only the numerical values explicitlyrecited as the limits of the range, but also to include all theindividual numerical values or sub-ranges encompassed within that rangeas if each numerical value and sub-range is explicitly recited.

For example, a concentration range of 0.5 to 400 should be interpretedto include not only the explicitly recited concentration limits of 0.5and 400, but also to include individual concentrations within thatrange, such as 0.5, 0.7, 1.0, 5.2, 8.4, 11.6, 14.2, 100, 200, 300, andsub-ranges such as 0.5-2.5, 4.8-7.2, 6-14.9, 55, 85, 100-200, 117, 175,200-300, 225, 250, and 300-400, etc. This interpretation should applyregardless of the breadth of the range or the characteristic beingdescribed.

As used herein, the term “about” means that dimensions, formulations,parameters, and other quantities and characteristics are not and neednot be exact, but may be approximated and/or larger or smaller, asdesired, reflecting tolerances, conversion factors, rounding off,measurement error and the like and other factors known to those ofskill. Further, unless otherwise stated, the term “about” shall for thesake of convenience also provide express support for the term “exactly,”regarding ranges and numerical data. In other words, support shall beprovided for the exact numerical value or range with which the term“about” is associated.

As used herein, a plurality of items, structural elements, compositionalelements, and/or materials may be presented in a common list forconvenience. However, these lists should be construed as though eachmember of the list is individually identified as a separate and uniquemember. Thus, no individual member of such list should be construed as ade facto equivalent of any other member of the same list solely based ontheir presentation in a common group without indications to thecontrary.

A goal for weight management or maintenance should be preservation oflean tissue and utilization of fat stores. Dietary protein provides anessential branched chain amino acid, leucine, to signal and regulateseveral processes in the muscle. For most humans, the majority ofdietary protein is consumed primarily at the evening meal which meansthat throughout the day the body does not have adequate levels ofleucine. Furthermore, the typical American consumes mainly carbohydratesfor breakfast and lunch signaling the body to store fat.

In some invention embodiments, a weight management or maintenancesystem, program, or method can include a nutritional supplementcomponent, a dietary component, an exercise component, or anycombination thereof. In some embodiments, the combination of two or morecomponents can provide unexpected and surprising benefits as compared touse of a single component. In some aspects, the two components can bethe nutritional supplement component and the dietary component.

Regarding the nutritional supplement component, in some embodiments,such component can include one or more nutritional or dietarysupplements administered to a subject that positively impact bodilyfunction, cognition, emotion, and/or metabolism. In some aspects, thedietary supplements can assist the body to utilize fat to meet energydemands, maintain muscle, and improve sense of wellbeing and motivation.Specific ingredients selected for inclusion in such dietary supplementseither have been, or can be, identified by gene expression studies. Oneexample of such selection process can be rodent studies, examiningsupplement impact to the subject's gene expression profile in muscle,adipose, and brain tissues. As such, in some aspects administration ofsuch supplements can regulate expression of certain genes in a subjecttaking the supplements that are involved in weight management issues,such as fat storage, muscle building, metabolic rate, energy, etc.

On such supplement is referred to herein as a “weight loss acceleratorformulation”. Such a supplement can be prepared in order to be used atcommencement of a weight loss, or management program in accordance withcertain invention embodiments. Such a supplement or formulation canprovide initial benefits that accelerate initial weight loss withincreased retention of lean muscle tissue. Effects, such as appetitesuppression, metabolic rate increase, and selection of fat burning ascompared to lean muscle tissue consumption for energy are sought withthe goal of aiding an initial burst of weight loss activity. It has beenfound that a subject who experiences dramatic initial weight lossresults when beginning a weight management program will gain enthusiasmand a mental and emotional boost that provides excitement and enthusiasmwhich helps them proceed into longer term phases of such a program witha greater percentage of success.

A number of specific ingredients can be included in such a weight lossaccelerator supplement, and such ingredients can be selected andcombined based at least in part on the gene expression results achievedduring testing. Examples of ingredients that can be combined intovarious formulations are shown in Table 1. In some embodiments, theamount of active agent present in each of formulations 1-8 can berepresentative of a single unit dosage form, such as one capsule,beverage, etc. as recited further below.

TABLE 1 Active Agents of Exemplary Accelerator Formulation DosagesIngredient 1 2 3 4 5 6 7 8 Garcinia Cambogia 1333 Glucomannan 2000Maltodextrin 9500 Opuntia ficus-indica fruit powder (Cactinea) 2000 20002000 2000 2000 2000 2000 Opuntia Milpa Alta Pomegranate extract 150 150150 150 Pomegranate extract EU 150 Pomegranate juice conc pwd 300 300300 Soy Protein Isolate 300 Red Orange Complex H 125 125 125 125 125 RedOrange Complex H Water 125 Red Orange juice pwd 375 375 Satiereal 177177 177 177 177 177 Amounts Per Day in mg for Label and Formula

An additional type of supplement that can be used as part of thesystems, programs, regimens, or methods recited herein is referred to asa “weight loss stimulator” formulation. Such a supplement can helpmaintain or elevate metabolic rate, energy, and stamina as well asreduce hormones and other endogenous substances produced by the body inresponse to stress, such as cortisol and inflammation among othereffects. Such formulation can aid the body's metabolism to utilize fatwhile maintaining muscle mass. A number of specific ingredients can beincluded in such a weight loss stimulator supplement, and suchingredients can be selected and combined based at least in part on thegene expression results achieved during testing. Examples of ingredientsthat can be combined into various formulations are shown in Table 2. Insome embodiments, the amount of active agent present in each offormulations 9-16 can be representative of a single unit dosage form,such as one capsule, beverage, etc. as recited further below.

TABLE 2 Active Agents of Exemplary Stimulator Formulation DosagesIngredient 9 10 11 12 13 14 15 16 Cayenne Powder 50 (50) 50 (50) 50 (50)50 (50) 50 (50) 50 (50) 50 (50) Chromium Yeast 0.12 (60) CitrusBioflavonoids 100 (210) 100 (210) 100 (210) 100 (210) 100 (210) 100(210) Citrus Bioflavonoids 100 (210) EU Coleus Forskohlii 500 (515)extract 10% Fucoxanthin 2.5 (263) 2.5 (263) 2.5 (263) (Seaweed extract)Glucomannan 2600 (2600) Green Tea Extract 35% 150 (429) Theanine GreenTea Extract 50% 300 (316) Green Tea Extract 97% 150 (158) 150 (158) 150(158) 150 (156) 150 (158) 150 (158) 500 (500) Lotus Leaf 300 (300)Magnolia Bark Extract 300 (300) Powergrape 400 (412) 400 (412) 400 (412)400 (412) Quercetin - Onion 250 (263) 250 (263) 250 (263) 250 (263) 250(263) Extract Quercetin - 75 (93.7) 75 (93.7) Saphora Japonica RedOrange Complex 250 (263) 250 (263) 250 (263) 250 (263) 250 (263) 250(263) ROCH Red Orange Complex 250 (263) ROCH EU Amounts Per Day in mgfor Label (Amounts Per Day in mg for Formula)

A further formulation or supplement that can be used as part of thesystems, programs, regimens, or methods recited herein is referred to asa “weight loss control” formulation or supplement. Such a supplement cancontinue to moderate appetite control, provide amino acids for musclemass maintenance, and maintain metabolism levels, among other effects. Anumber of specific ingredients can be included in such a weight losscontrol supplement, and such ingredients can be selected and combinedbased at least in part on the gene expression results achieved duringtesting. Examples of ingredients that can be combined into variousformulations are shown in Table 3. In some embodiments, the amount ofactive agent present in each of formulations 17-24 can be representativeof a single unit dosage form, such as one capsule, beverage, etc. asrecited further below.

TABLE 3 Active Agents of Exemplary Control Formulation DosagesIngredient 17 18 19 20 21 22 23 24 Banaba Extract   48 (49.4) ChromiumChelate Cocoa Powder 750 (788) 750 (788) 750 (788) 750 (788) 750 (788)750 (788) 750 (774) 750 (788) Green Tea Extract 35% Theanine 150 (450)150 (450) 150 (450) 150 (450) L-Carnitine (as tartrate) Maltodextrin1228 (1228) Pomegranate extract 250 (258) 250 (258) 250 (258) 250 (258)250 (258) 250 (258) Pomegranate extract EU 250 (258) Pomegranate juicepowder 250 (258) Red Orange Juice Powder 250 (258) Tart Cherry powder300 (309) 300 (309) 300 (309) 300 (309) 300 (309) 300 (309) 300 (309)300 (309) Theanine 98% 150 (161) 150 (161) Amounts Per Day in mg forLabel (Amounts Per Day in mg for Formula)

The foregoing formulations can be utilized in any manner that supportsor achieves a specifically desired weight management or maintenanceprogram, method or regimen. In one embodiment, the formulations can beadministered simultaneously for a predetermined or specified duration oramount of time. In another aspect, the formulations can be administeredseparately at specifically desired or determined times as needed inorder to provide or assist in the weight maintenance program.Furthermore, in yet a further aspect, all of the formulations can beinitially administered and then one formulation removed fromadministration while the other two are maintained, and then a secondformulation can be removed while one is maintained. In one embodiment,the accelerator, stimulator, and control formulations can beadministered simultaneously for a given time, duration, or period. Next,the accelerator formulation can be removed and the stimulator andcontrol formulations continued. Finally, the stimulator can be removedwhile the control formulation is continued. In another embodiment, theaccelerator formulation can be administered first for a specifiedperiod, and then stopped and the stimulator formulation can beadministered for a specified period of time and then stopped, andfinally, the control formulation can be administered for a specifiedperiod of time. In a further embodiment, the accelerator formulation canbe administered for a specified period of time and then the stimulatorand control formulations can be added, either consecutively orsimultaneously.

In one aspect, the accelerator, stimulator and control formulations canbe administered for a specific period of time. In some aspects, theperiod or amount of time may be the same. In other aspects, the periodsmay be different. In one aspect, the amount of time may be from about 1week to about 1 year. In another aspect, the amount of time may be fromabout 2 weeks to about 2 years. In an additional aspect, the amount maybe about 15 days. In another aspect, the amount may be for about 90days. In one embodiment, a weight management or weight loss system,program, or method, can include administration of a weight lossaccelerator formulation for 15 days and administration of a weight lossstimulator and a weight loss control formulation for 90 days. In suchembodiment, all three formulations or supplements are taken for thefirst 15 days of the program or method and then the weight lossaccelerator is discontinued and the weight loss stimulator and controlformulations are taken for the remainder of the 90 day period.

In addition to variations in timing and duration, the dosage or amountof each supplement can be varied. Further the dosage type can be varied.In one aspect, the formulations can be oral formulations selected fromtablets or capsules, or can be a foodstuff, such as a beverage(including a powder to be added to liquid and consumed as a beverage),shake, bar, pastry, a confection, etc. In one aspect, the supplements orformulations can be a beverage. In another aspect, the supplements orformulations can be capsules. In yet a further aspect, the weight lossaccelerator formulation can be a beverage and the weight loss stimulatorand control formulations can be a capsules.

Regarding dosage amounts in one aspect, the formulations recited hereincan be administered to a subject from 1 to 4 times per day. In oneaspect, the number of daily administrations may be 1. In another aspect,the number of daily administrations may be 2. In yet a further aspect,the number of daily administrations may be 3. In still a further aspect,the number of daily administrations may be 4. In one specificembodiment, a weight loss accelerator formulation as recited herein canbe administered once per day. In another embodiment, the weight lossstimulator and control formulations can be administered two times perday. In one aspect, administrations can be with meals. In anotheraspect, administration can be just prior to meals, for example 15 to 20minutes prior to a meal. In one aspect, the number of unit dosage formsreceived at each administration can vary depending on the amount ofactive ingredient in each. In some embodiments, a single unit dosage(i.e. one beverage or one capsule) may be sufficient to provide thetotal amount of active agent desired at the administration time. Inanother embodiment, multiples of each single unit dosage form (i.e. two,three, four, capsules) can be administered in order to provide the totalamount of active agent desired at the administration time. In onespecific embodiment, one unit dosage of a weight loss activatorformulation can be administered, for example, one beverage. In oneembodiment, such unit dosage can have one or all of the activeingredients in the amounts of the exemplary unit dosages recited inTable 1. In some aspects, the amount of the active agents may be afraction, or a multiple of thereof, such as one quarter, one half,double, triple, quadruple, etc. Nearly any amount or fraction of activeingredient can be used in specific unit dosages, which is sufficient tobe deemed an effective amount. This same principle is true for theweight loss stimulator and control formulations recited in Tables 2 and3 respectively.

In one embodiment, a weight loss activator formulation may be providedas a powder having the active agents recited in the formulations ofTable 1, in the amounts specified as a single unit dosage. In someembodiments, such a dosage can be administered one time per day for 15days at the commencement of a weight management program or method. In anadditional embodiment, a weight loss stimulator formulation may beprovided as a capsule having the active agents recited in theformulations of Table 2, in the amounts specified as a single unitdosage. In some embodiments, such a dosage can be administered 1-3 timesper day. In one embodiment, such a dosage can be administered 3 timesper day and in some embodiments can be administered just prior to eachmeal, such as 15-20 minutes prior. In other embodiments, the amountsshown in Table 2 can represent a total daily dosage and single unitdosages can be administered as a fraction thereof, for example, 3capsules administered daily in order to provide the total amount ofactive agent listed. In yet a further embodiment, a weight loss controlformulation can be provided as a capsule having the active agentsrecited in the formulations of Table 3, in the amounts specified as asingle unit dosage. In some embodiments, such a dosage can beadministered 1-4 times per day. In one embodiment, such a dosage can beadministered 4 times per day. In one embodiment, unit dosages (i.e. twocapsules) can be administered twice per day. In a further embodiment,such administration can occur just prior to a meal, such as 15 to 20minutes prior. In other embodiments, the amounts shown in Table 3 canrepresent a total daily dosage and single unit dosages can beadministered as a fraction thereof, for example, 2 capsules twice dailyfor a total of 4 capsules per diem.

In addition to the active agents (a further description of which isprovided below), a number of other ingredients can be included in orderto provide specific dosage forms. For example, carriers, thickeners,diluents, etc. such as gelatin, starch, cellulose (includingmicrocrystalline cellulose), silicon dioxide, water, etc. can be used.However, in other dosage forms, only the active agents may be presentwithout the substantial addition of other ingredients.

In one embodiment, a weight loss accelerator formulation is designed toassist a subject begin to lose weight and see initial success immediate,observable changes in achieving a healthy body weight (within the first15 days). The weight loss accelerator formulation can in one embodiment,be a powder that is designed to easily be mixed into an amount of water,for example, approximately 240 mL of water or other beverages and to beconsumed once a day.

In one embodiment, the ingredients of the weight loss acceleratorformulation can include Prickley Pear Cactus fruit powder (i.e. opuntiaficus-indica extract), red orange complex (i.e. citrus sinensis fruitextract), Satiereal® Saffron (i.e. crocus sativa extract), andpomegranate juice powder concentrate (i.e. punica granatam fruitextract), and maltodextrins.

Red orange extract can inhibit damage caused by oxidative stress andinhibit the accumulation of body fat. The accumulation of unwanted bodyfat is influenced by a number of factors including inflammation,oxidative stress and abnormal insulin signaling. Fat accumulation can beinhibited by antioxidants, including those found in blood oranges. Forexample consumption of blood orange juice lead to a reduction in bodyweight, inhibited fat accumulation and attenuated diabetes prevalence inan obese rat model. Furthermore, gene expression analysis of the adiposetissues demonstrated that the blood orange juice feeding opposed amajority of the gene expression changes elicited by the high fat diet.This data supports a causal role between gene expression changes andinhibition of fat accumulation by blood orange. The positive effectselicited by the blood orange juice were not observed with typical orangejuice (Navelina), indicating that factors unique to the blood orangevariety confer its anti-obesogenic benefits.

Crocus sativus is a commonly used spice (saffron) in India, Persia,Greece, and Italy. It is derived from stigmas harvested from Crocussativa L, the saffron crocus. This spice is commonly grown in theeastern zone of the Mediterranean basin. Saffron has been an importantflavoring in risotto, bouillabaisse, and paella, and in Indian andPersian aromatic rice dishes, sauces, and desserts. Historical uses ofsaffron include easing digestion of spicy food, soothing of irritatedstomachs, and in the Middle East to treat depression and melancholia. In200 mg of a crocus sativus extract there is 33 mg of saffron, equivalentto that found in about ½ serving of paella. Crocus sativus extract isalso a source of 3 natural compounds found in saffron, i.e. Crocin(color), picrocin (bitterness), and safranal (odor and aroma). Crocussativa has been consumed safely for centuries, and the extract ofSaffron is listed in US FDA GRAS lists (21 CFR 182.20).

Crocus sativus extract can effect satiety by decreasing stress andimproving emotional health. One substance in the body that influencesfood intake is serotonin. Serotonin is a neurotransmitter thatinfluences anxiety, mood, appetite, satiety, and compulsiveness. Crocussativus has positive influences serotonin levels and leads to improvedemotional behavior, exertion of a satiating effect, and decreasedcompulsive snacking.

An edible fruit native to Persia, pomegranate is grown and consumedthroughout the world, including the United States, and has been reveredthrough the ages for its medicinal properties. Pomegranate juice or itsextracts have positive effects on fat reduction; many of these effectshave been attributed to their very high levels of antioxidants,including polyphenols, flavonoids, anthocyanins, and tannins.Pomegranate extract provides flavor and color to this product but alsoadds benefits to help suppress appetite and influence gene expression.

Maltodextrins (oligosaccharides) are complex carbohydrates and can beincluded in the present formulations to provide some energy source butprevents the insulin spike from simple carbohydrates. They provide amore sustained release of carbohydrates vs simple carbohydrates.Oligosaccharides have been shown to influence hormones that controlappetite.

Glucomannan is a water-soluble fiber that is derived from the root ofthe konjac plant (Amorphophallus konjac). Amorphophallus konjac wasoriginally cultivated in China over 2,000 years ago, and spread to Japanaround 500 A.D. Historically the tuber has been processed and preparedas flour for noodles and a jelly called “konjaku”.

Water soluble glucomannan has been shown to slow glucose release fromthe digestive tract in amounts proportional to their viscosity. Thus,glucomannan's glucose stabilizing benefits are likely to be in largepart due to its high viscosity. When a carbohydrate meal is consumedwith glucomannan, it forms a dense gel-matrix leading to a more gradualrelease of sugar into the blood stream, which in turn reduces theinsulin spike that is typical after a meal. Glucomannan leads to areduction in blood sugar variation, and the meal is more like alow-glycemic index (GI) meal rather than a high-GI entity. All this mayhelp increase satiety from a meal.

Generally, the weight loss stimulator formulations of the presentinvention are designed to provide nutritional support for weightmanagement by increasing metabolism and achieving a visible change insilhouette. Lean body tissue (skeletal muscle) is the most metabolicallyactive tissue in the body, even while the body is at rest. The greateramount of lean body mass that an individual has, the greater theirResting Metabolic Rate (RMR), which is the amount of kcals that theyburn while at rest. During any weight loss program, individuals loseboth body fat (a desired effect) and lean body mass (muscle) (anundesired effect) as they lose total kilograms of body weight.Consequently, even if individuals achieve their goal body weight, theytypically have lower lean body mass at the end of the diet and acorresponding lower RMR. The result is that it is more difficult tomaintain weight loss because of the depletion of lean body mass andlower metabolic rate at rest. Therefore, one key to achieving and moreimportantly, maintaining a healthy body weight, is to retain as muchlean body mass as possible during any weight loss program. Anintervention that increases the mobilization and utilization/oxidationof fat as a fuel source during weight loss would in turn spare lean bodymass as the body would be burning fat rather than protein (muscle) tofuel activity. Weight loss stimulator formulations as recited herein arespecifically formulated to support increased fat metabolism andpreservation of lean body mass during weight loss. The ingredients canin some embodiments include without limitation: Red Orange Complex,Green Tea Extract, Fucoxanthin, Whole Grape Extract, Onion Extract(standardized for quercetin), Citrus Bioflavonoids and Cayenne Powder.

As previously mentioned, red (Moro) oranges (also known as bloodoranges) are a unique variety of citrus fruit in that they contain anunusual group of antioxidant pigments known as anthocyanins that givethe citrus fruit a dark red, almost purple, color. Red oranges have beenstudied for their unique effects both in juice and in extract forms.Weight loss stimulator formulations as recited herein can include a redorange extract that has been shown to inhibit damage caused by oxidativestress and to inhibit the accumulation of body fat.

Significant thermogenic (energy expenditure at rest), fat burning andweight loss can be achieved by administration of green tea extract. Forexample, supplementation with caffeinated green tea (375 mgcatechins/day) can increase total energy expenditure, includingincreased fat oxidation in subjects. Caffeine alone has no effect onthermogenesis or fat oxidation (fat burning) suggesting that it is thegreen tea catechins, not the caffeine responsible for the positivethermogenic and fat burning effects. Similarly, consumption of green teacan lead to reductions in overall body weight, waist circumference andtotal fat mass, further supporting the role of green tea in promotingweight loss, specifically fat loss. Of note, waist/hip circumferencesand visceral, or ‘belly fat’ can all be preferentially reduced. Inaddition to directly reducing body fat stores, the preferential use offat as a fuel reduces spares protein from oxidation for fuel, thusprotecting muscle protein. This muscle sparing effect by green tea canoccur where green tea supplementation elicits a sparing of lean musclemass.

Brown seaweed extract (containing a xanthophyll-carotenoid, Fucoxanthin)can increase fat metabolism, particularly in animals on a high fat diet.For example, mice fed a high fat diet and supplemented with fucoxanthinfor 10 weeks experienced a significant decrease in body weight andadipose tissue. Brown seaweed extract containing fucoxanthin increasesfat oxidation (burn) as well as heat production in the mitochondria ofadipose tissue. Subjects further benefit from reductions in liver andbody fat. In some instances, brown seaweed extract can improve bodyshape even in the absence of weight loss. During a study, presentinventors observed that brown seaweed extract and pomegranate seed oilfor 12 weeks led to reductions in thigh circumference and other key bodymeasurements in the absence of weight loss. As this was not a weightloss study, but instead designed to investigate the effects of thesupplement on body shape, these findings support the premise that brownseaweed extract can improve body shape/silhouette, even in the absenceof weight loss.

Diet and exercise are typically components of an effective weightmanagement program. Whole grape extract has been included in embodimentsof weight loss stimulator formulations facilitate exercise performanceand post-exercise recovery. Whole grape extract supplemented at 400mg/day in handball players, significantly enhanced overall physicalperformance (19.5 vs. 4.4%) and protected against muscle damage comparedto a control group. The enhancement of physical performance directlycorrelated with a decrease in plasma markers of muscle damage (creatinekinase (CPK)). By protecting against exercise-induced muscle damage andenhancing recovery following exercise, whole grape extract supports theexercise component of the program. Exercise contributes to fatmetabolism and building and retention of lean muscle mass.

Quercetin (i.e. onion extract) can attenuate both insulin resistance(the inability to use insulin effectively for glucose metabolism) andinflammation associated with obesity. In human adipocyte (fat cell)cultures, quercetin inhibits the expression of pro-inflammatory genes.In obese rats, quercetin at 10 mg/kg-body weight reduced body weightgain. Remarkably, in 3T3-L1 pre-adipocytes, quercetin induced apoptosis(cell suicide) in a dose- and time-dependent manner, and had the mostpowerful effects on these cells of the 6 flavonoids tested suggestingthat quercetin may have the ability to reduce the total number of fatcells in the body. Quercetin supplementation reduces abdominal fat,lower systolic blood pressure and attenuates abnormal structure andfunction changes in heart and the liver in rats on a high-fat,pro-inflammatory diet. Quercetin supplementation also opposed negativechanges in gene expression elicited by the high fat diet. Studies inmice have confirmed these positive effects of quercetin on geneexpression related to its anti-obesogenic, anti-oxidative effects andanti-inflammatory benefits. Analogous to the effects of whole grapeextract, quercetin improves exercise tolerance in mice and enhancesphysical performance in humans, indicating that it too, is a supportiveingredient for the promotion of exercise in a weight management program.

Citrus fruit is an exceptionally good source of bioflavonoidantioxidants. Flavonoids may help to promote the achievement andmaintenance of a healthy body weight, as they confer a number ofbenefits associated with weight management: antioxidant function,cellular protection, and blood glucose control. For example, overweightcats fed a saturated fat diet fortified with citrus bioflavonoids,responded with lower energy intakes, lower plasma lipids and lowerconcentrations of oxidative damage markers, suggesting that citrusbioflavonoids may support weight management. In some embodiments, thecitrus bioflavonoid complex ingredient in weight loss stimulatorformulations is derived from a blend of 100% natural citrus extracts,including oranges, limes, lemons, tangerines, and grapefruit, and isclassified as Generally Regarded as Safe.

Capsaicin, an active component of hot peppers, is commonly used as foodstuff around the world and is typically consumed in the form of cayennepowder. Several epidemiological studies have identified that populationsthat consistently consume capsaicin have lower incidences of obesity.Capsaicin has been shown to increase thermogenesis through enhancedadrenal gland secretion of catecholamines, a class of substances knownto increase metabolic rate. For example, in a comparison rats fed eithercapsaicin or saline (control group) there was a decrease in body weightof 8% in mice fed capsaicin, a result attributed to increases metabolismin the capsaicin treated group.

Chromium (Cr) supplementation promotes healthy blood glucose metabolismwithout any documented side effects. Clinical studies show that Crsupplementation improves glucose tolerance, and decreases hemoglobinglycosylation in people with type 2 diabetes.

An important component of achieving and maintaining healthy body weightis appetite control. Furthermore, as someone begins a weight lossprogram it is important to have willpower as well reduction of stress tohelp achieve the desired goals. Weight loss control formulations asrecited herein assist in the control of appetite and to providenutritional support while restricting energy. Further, such formulationscomprise ingredients that promote relaxation, such as theanine,facilitate recovery from exercise such as tart cherry powder, andregulate blood sugar and inflammation, which in turn may help controlappetite. The net effect can be aid in controlling appetite and anxiety,and recovery from exercise, thereby facilitating adherence. Additionallyreduction of fat can be increased. This formulation contributes towillpower and assists in healthy weight management. The ingredients insome embodiments may include without limitation: cocoa powder, green teaextract (35% theanine), tart cherry powder, chromium chelate,pomegranate extract or juice powder.

In many cultures around the world, chocolate and cocoa are very popularfoods, where cocoa has both food/flavor and medicinal benefits.Chocolate is a rich source of flavanols (includingepicatechin/catechin), more than beans, cherries, tea, and wine. Cocoaconsumption can aid in control weight and appetite. It has been foundthat mice fed cocoa powder along with high fat or normal fat dietsexperience reduced weight gain, attenuated insulin resistance, andreduced high fat induced liver disease. These benefits seem to be viacocoa powder's influence on effects of pro-inflammatory pathways inwhite adipose tissues.

In addition to the above-recited benefits, green tea or green teaextract is thought to decrease anxiety and increase relaxation. Greentea extract containing theanine may improve relaxation. For example,subjects fed theanine at 50-200 mg/day experience a sense of relaxationin approximately 30-40 minutes.

Tart cherries contain polyphenols that have particularly goodantioxidant effects. Interestingly tart cherries also haveanti-inflammatory and positive effects on body weight. Tart cherry alsodecreases the gene expression of inflammatory markers.

Exercise can be an important part of weight management and tart cherriespositively influence recovery from exercise and inflammation followingexercise. Acute muscle damage is caused by long distance running,resulting in inflammation and decreased force production. The ingestionof tart cherry juice (TCJ), improve delayed onset of muscle soreness(DOMS).

As previously mentioned, Pomegranate juice or its extracts have positiveeffects on fat reduction, many of which are attributed to their veryhigh levels of antioxidants, including polyphenols, flavonoids,anthocyanins, and tannins. Various mechanisms have been proposed on howdifferent extracts of pomegranate help in fat reduction, one of which isthe effects of pomegranate fruit extract on resisting.

Pomegranate extract can in some embodiments, be included as a componentof the weight loss control formulations and supplements recited herein,providing a number of supportive benefits for weight management.Firstly, overweight and obesity are associated with increased levels ofstress, both psychological and oxidative, as well as inflammation.Higher levels of stress and inflammation can also make it more difficultto lose and maintain weight loss. Furthermore, increases in antioxidantstatus are associated with healthy body weights. Pomegranate juice andextracts attenuate stressors and inflammation and increase antioxidantstatus. The pomegranate extract in the present weight loss controlformulations contribute to the management of both stress andinflammation in support of weight management and body weightmaintenance.

Secondly, it is well established that insulin insensitivity andsubsequent lack of glucose control and increased glucose fluctuationsare directly related to food cravings. Pomegranate modulates glucosesecretion and increase insulin sensitivity. Thus, pomegranatecontributes to a reduction in food cravings in overweight and obesepersons.

Further, energy levels and attitude towards physical activity directlyinfluence adherence to any weight management program. Consumption ofpomegranate extract not only improves the response to exercise training,but also reduces soreness and recovery rates following exercise. Byenhancing the response to and recovery from physical activity, thepomegranate delivered in the present weight loss control formulationssupports increased physical activity, making it easier to participate inphysical activity on a daily basis. By reducing soreness, physicalactivity is a more positive experience for subjects. Pomegranate extractprovides flavor and color to the present formulations and also addsbenefits to help suppress appetite and influence gene expression.

Certain embodiments of the present weight management systems, programs,or methods can include a dietary component in addition to theabove-recited supplement regimen. In one embodiment, important nutrientsare consumed in a volume and amount that is appropriate for anindividual's body size. One mechanism of measuring an appropriate amountfor a body is based on the subject's (i.e. individual's) hand size. Assuch, in one embodiment, a serving size of a given food or nutrient canbe approximately or about the size of the subject's hand.

In addition to portion size, overall intake volume is impacted by thefrequency or number of servings consumed in a day. Yet further, overallnutrition is impacted by the type of nutrients or foods consumed. In oneembodiment, a dietary plan or regimen that is part of a weightmanagement system, program, or method may include from 3 to 8 servings(i.e. portions) of protein per day, from 1 to 4 servings of vegetables,from 1 to 4 servings of fruit, and from 1 to 4 servings of complexcarbohydrates. In another embodiment, such a regimen may include 6servings of protein, and 2 servings of vegetables, fruit, and complexcarbohydrates per day (i.e. a 6-2-2-2 plan). Again, the portion orserving sizes are based on (i.e. roughly equivalent or equivalent to) asubject or individual's hand size. Hence, appropriate serving size forthe specific individual's body is provided.

In some embodiments, the dietary plan or regimen may stipulate specifictiming of consumption for the above-recited foods or nutrients. In oneaspect, protein intake or consumption timing is specified. Protein is amacronutrient that plays several important roles in the body includingproviding amino acid building blocks for enzymes, protein structures(muscle, bone and other tissues), signaling molecules and other nitrogenrequiring functions. Protein is also required for muscle cell signaling(e.g. leucine), satiety, thermogenesis, blood glucose control,maintenance of bone integrity, cardiovascular health, and calciumabsorption, in addition to maintenance of lean muscle.

Dietary protein has several anti-obesigenic properties. It influencesthe greatest amount of satiety per calorie compared to othermacronutrients (fats and carbohydrates), influences several appetitehormones, increases utilization of adipose tissue and maintains musclemass during energy restriction, increases diet induced thermogenesis,and improves insulin resistance.

Historically, protein intake recommendations have been based onpercentages of macronutrients from the diet, typically, 20-30% ofcalories from protein. Nutritionists now agree that this is a flawedapproach. The most recent nutritional science confirms that proteinintakes should be based on absolute protein levels, gramsprotein/kilogram body weight of the individual. This point is especiallyimportant when considering reductions in caloric intake such as when aperson is dieting. For example, an individual that typically consumes1500 kcals/day, 20% kcals from protein would consume 75 g ofprotein/day, but if they went down to 1,000 kcals/day, 20% kcals fromprotein would provide only 50 g of protein/day. Fifty grams ofprotein/day is not even enough protein to replace normal nitrogenlosses, let alone optimally support thermogenesis, satiety, cellsignaling, and calcium absorption, bone matrix remodeling and glycemiccontrol. By basing intakes on absolute protein, rather than percentageof calories from the diet, the 6-2-2-2 dietary or eating plan maintainsprotein intakes even as calories are reduced, ensuring that adequateprotein is available to support all protein-related metabolic processes.In other words, as a person restricts energy (kcals) on the 6-2-2-2eating plan, they reduce energy from fat and carbohydrate, maintainingprotein intakes to support essential protein metabolic functions.

The most recent recommendations for optimal protein intake are based onabsolute protein intakes. For adults ≧1.6 g/kg body weight/day up to 2.5g/kg body weight/day is considered optimal and the Institute of Medicine(IOM) has concluded that there is no Upper Limit Risk for proteinintake.

Based on the latest recommendations, the protein intake for a 60 kgindividual, 1.6 g/kg body weight/day would deliver 96 g/day. The 6-2-2-2eating plan provides dietary protein proportional to body size, 6fist-sized portions of protein/per day delivering ˜15 g protein/fistsize portion. A larger individual with a larger hand size will thereforeconsume more protein than a smaller person with a smaller hand sizeensuring that each individual will consume the optimal amount of proteinproportional to his/her size. In one embodiment the dietary or eatingplan accommodates for 2 protein portions be consumed at each meal.

In the past, concerns have been raised that a high protein dietincreases bone loss, but modern research has debunked this theory. Infact, bone volume is composed of ˜50% protein and protein is essentialfor bone health throughout the lifespan. Previously issues were raisedthat protein increased urinary calcium excretion and that thereforeprotein increased bone loss. Recent studies have consistently reportedthat a high protein diet actually increases absorption of dietarycalcium at a much higher rate than urinary calcium losses such that highprotein intakes are associated with a net increase in calcium in bone.Furthermore, studies have demonstrated that high protein diets increasebone mineral content and reduce the risk of fractures and high proteindiets combined with increased calcium, increased bone mass even further.A year-long study comparing a higher protein diet similar to the 6-2-2-2eating plan versus a traditional low fat-high carbohydrate diet reportedthat the higher protein group maintained bone mineral density after oneyear in contrast to the low protein diet group that actually lost bonemineral density. This study highlights the issue that weight loss leadsto a loss of both bone and lean muscle, and that this loss may beattenuated by the higher protein 6-2-2-2 eating plan.

Concerns have also been raised about the safety of high protein dietsfor diabetics, but again, recent research concludes that protein isessential for glycemic control and is actually protective in diabetics.Higher protein intakes have been demonstrated to improve glycemiccontrol, attenuate hyperinsulinemia and are associated with reducedlevels of glycosylated hemoglobin (HbA1c), a key marker of long-termblood glucose control in diabetics. These learnings indicate that notonly is a high protein diet safe for diabetics, but is actuallybeneficial.

Lean muscle is the most metabolically active tissue in the body, playinga key role in thermogenesis, energy balance and weight management.Unfortunately, loss of lean muscle is a typical side effect of anyweight loss program. The loss of metabolically active lean muscle duringweight loss makes it very difficult for an individual to maintain theirweight loss over time. Consequently, dieters that lose muscle massduring a weight loss program are more likely to regain the lost weightthan those that maintain their lean muscle during weight loss. Higherprotein diets, such as the 6-2-2-2 plan, attenuate the loss of leanmuscle during weight loss, maintaining this metabolically active leantissue and supporting weight maintenance following the 90 days of theplan.

In addition to sparing lean muscle and preventing bone loss during aweight management program, the dietary protein delivered in the presentdietary or nutrition regimens of the present invention, such as the6-2-2-2 eating plan, also provide optimal levels of the essentialbranched chain amino acid leucine. Leucine acts as a signaling moleculestimulating the synthesis of new muscle following a protein-containingmeal. Leucine promotes muscle synthesis by signaling changes in geneexpression. In order to stimulate protein synthesis, a minimum amount ofleucine (2.5-3 g/meal) is required. On average, 30 grams of protein in asingle meal delivers enough leucine to stimulate muscle synthesis. Inorder to address this issue, the 6-2-2-2 eating plan distributes proteinintake evenly throughout the day. Most people eat the majority of theirprotein during their evening meal which means they consume predominatelycarbohydrates in morning and afternoon meals, signaling the body tostore fat, not burn it and only build protein after the evening meal.Interestingly, most people consume 70-90% of protein in the eveningmeal. It is proposed that by distributing the dietary protein to achievebetween about 10 g to 30 g of protein per meal, lean tissue isstimulated and the body will draw upon adipose tissues to meet energydemands, thus impacting overall weight. (FIG. 1)

As a result, in one aspect, a dietary component of the present weightmanagement or maintenance systems, programs, or methods may include aplan where a substantial amount of protein is consumed at each meal. Inone aspect, the amount may be at least about 10 grams. In anotheraspect, the amount may be at least about 20 grams. In a further aspect,the amount may be at least about 30 grams. In a further aspect, theamount may be from about 10 grams to about 50 grams.

It should be emphasized that the dietary component of the present weightmanagement systems, programs, or methods are very different from otherknown weight loss plans as the present plans focus on maintainingoptimal levels of protein and distributes that protein evenly throughoutthe day. The exemplary 6-2-2-2 program or plan delivers moderate amountsof protein in contrast to very high protein diets such as “Atkins” and“Paleo Diet”. Since the exemplary 6-2-2-2 eating plan is balanced andbecause it is designed to deliver optimal protein levels, as well asfruit and vegetable intakes, it can therefore be continued long afterother portions of the present weight management systems, programs, andmethods are completed, or example, the 90 day plan described herein. Byhelping individuals to achieve a healthy eating lifestyle, the exemplary6-2-2-2 eating plan can be maintained throughout one's life.

The one form in which protein may be consumed under the present dietaryregimens or plans is using protein containing shakes. Such shakes canmake it easy to incorporate a minimum of 30 grams of protein per meal.Exemplary shakes can contain at least about 12-15 grams of highlybiologically available protein (for example whey protein) and a goodsource of an essential amino acid, leucine. Whey protein offers a numberof benefits as well as influences metabolic rate and thermogenesis. Wheyprotein ingestion along with energy reduction has shown to increaseutilization of adipose tissue (burn fat) and maintenance of lean bodymass as compared to energy reduction alone. Furthermore whey protein hasbeen shown to be superior (i.e. soy) to other sources of protein inutilization of adipose tissue, increase weight loss and preserve leanbody mass.

In one embodiment, a shake can be formulated to include tart cherrypowder that has been identified as a food ingredient that shifts geneexpression in muscle and adipose tissue in a positive direction andsupports healthy weight loss as previously mentioned.

EXAMPLES

A study was undertaken to understand the effects of natural compounds assupplements to assist along with an eating plan to influence bodycomposition changes and safety through laboratory values in subjectsparticipating in a 3 month study. The study was descriptive in natureand to understand the expected results of males and femalesparticipating in the study.

Given the promising results, the excellent safety profile, and thecomplementary mechanisms of action Fucoxanthin, Citrus bioflavonoids,Onion extract, Capsicum, Dark chocolate extract, and Tart cherry powder,it was hypothesized that a proprietary blend of these ingredients mayimprove the overall weight loss along with a healthy dietary program.

Potential subjects who met the inclusion and exclusion criteria werescreened and enrolled into the study. Seventy three healthy subjectswere recruited to participate in this study. There were 5 female subjectthat decided to withdraw their consent, one female was withdrawn becauseof non-compliance with product consumption, one male subject was ascreen failure, and one male subject was lost to follow-up which left atotal of 65 evaluable subjects (females n=44 and males n=21} whose agesranged from 25 to 65 years and body mass indexes (BMI) ranged from 25-40kg/m².

The study inclusion criteria were as follows:

-   -   1. Females and Males aged 25-65 years    -   2. Signed informed consent    -   3. BMI between 25 and 40 kg/m2    -   4. A resting normotensive blood pressure is defined as a        systolic blood pressure between 90-145 mmHg and a diastolic        blood pressure of 50 90 mmHg    -   5. Use of effective method of contraception by females of        childbearing [potential and agreement to continue to practice an        acceptable method of contraception for the duration of their        participation in the study]. Acceptable methods of contraception        include oral, injectable, or implantable contraceptives;        intrauterine devices, diaphragm plus spermicide; abstinence        (must agree to use double-barrier method if they become sexually        active}, transdermal patch, or any double barrier method        including a vasectomized sexual partner. Women who have had a        hysterectomy or tubal ligation at least 6 months prior to Visit        for who have been post-menopausal for at least lyear prior to        Visit 1 are not considered to be of childbearing potential.    -   6. Ability to speak and understand English    -   7. Willing to fast the morning of visit where blood samples are        taken

Exclusion Criteria

-   -   1. Self-reported chronic condition that may affect subject        safety (e.g., diabetes, cardiovascular disease) or significantly        impact product effectiveness (e.g., chronic fatigue)    -   2. Pregnancy/suspected pregnancy, breastfeeding or planning to        become pregnant during the course of the study.    -   3. Use of Antihypertensive medication for less than 4 months or        unregulated clinically blood pressure.    -   4. Having undergone gastroplasty or bariatric surgery in the        past 10 years.    -   5. Taking medication (e.g., thyroid medication), must be stable        for at least four months.    -   6. Allergies to any ingredients contained in the Nutritional        Supplement.    -   7. Medical treatment for insomnia or depression within 30-days        prior to the screening visit.    -   8. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine        patches) use within 30-days prior to the screening visit.    -   9. Planned surgical procedure during the course of the study.    -   10. Currently participating in another study or have done so        within 30 days prior to the screening visit or is likely to        enroll in another clinical or nutritional study.    -   11. Currently taking any medication or supplement for the use of        weight loss must be discontinued prior to Visit 1Baseline Day 0.    -   12. Currently participating in a weight loss program or        participated in a weight loss program in the past 6 months.        The study was conducted with good clinical practices and        standards. Measurements were made at Baseline, 14 days, 30 days,        60 days, 90 days (see schedule of events) as well as with        accredited laboratories.

Schedule of Events

This study was an Open-label, Single-Center Study on the Effects of aNutritional Supplement Combination on Body Weight Management over a90-day period in Men and Women ages 25 to 65.

Clinical Visit Number V1 Day 0 Screening/ V1 Day 15 ± V1 Day 30 ± V1 Day60 ± V1 Day 90 ± V6 Day 97 ± Procedures Baseline 3 Days 3 Days 3 Days 3Days 3 Days Inclusion/Exclusion criteria review - inform X subjects ofbonus possibility and they may be asked to share their experience at theend of the study Subject Informed Consent X  x¹  x¹  x¹  x¹ MedicalHistory review of systems X Prior and concomitant medication history X XX X X Height X Weight & BMI X X X X X Body measurements (waist, hip,arm, ankle) X X X X X Vital signs (BP, pulse, resps. & temps)  X³  X³ X³  X³  X³ Abbreviated Physical Exam X X Photos (shots/sports bra orfull swim suit) X X X X X Fasting Safety Labs (chemistry, hematology, XX X Coagulation) BioPhotonic Scanner X X X X X Bod pod: Body FatAnalyzer Test X X X X X Resting Metabolic Rate Test (RMR) X X X X X GeneExpression Panel whole blood and Lipid X X X Panel Pregnancy test  x²DPWA Pulse Wave Analyzer X X Nutritional Supplement Dispensing X X XUnused Nutritional Supplement Collection X X X X Nutritional SupplementAccountability  X⁴  X⁴  X⁴  X⁴ Monitor of Adverse Events X X X XQuestionnaire IWQOL Hunger/Appetite + X X X questionnaire Diet Menu -6-2-2-2-2 Approx 1,200 X X X X X X calories/day M/F Calibrate thePedometer X Daily Diary X X X X X ¹For Amended ICF's ²Urine at Visit 1³Vital signs collected after the subject has been sitting for a minimumof 5 minutes and collected using subjects dominant arm

Efficacy Assessment

Weight and body compositional changes were determined by BodPod, restingmetabolic rate (CPET/Quark), body measurements (Waist, Hip, Arm, andAnkle Circumference), and questionnaires to determine quality of lifeand hunger changes.

Safety Assessment

Safety was assessed by changes in blood chemistries/hematology, anddescription and tabulation of all adverse events (AE's), nutritionalsupplement emergent AEs (TEAE's), classified by severity grade,relatedness to the Nutritional Supplement, and organ class according tothe investigator's judgment.

Serious adverse events (SAE's) were followed by the investigator untilthey had resolved, reached a stable condition, or the subject was lostto follow-up. Vital signs (heart rate, blood pressure, respiratory rate,and oral temperature) were collected at Visits 1 through 5 using thesubject's dominant arm.

Descriptive Analysis

The results from this study were meant to be descriptive in nature so asto have an understanding what individuals can expect when using thesystem (both from a safety and efficacy standpoint). A comparative groupwas also included regarding the gene expression results (in a subset ofsubjects completing the 90 day weight management system). In this work agroup of subjects was used from another clinical study in which geneexpression work was performed in the identical manner but the subjectswere in a BMI range of 22-26. This comparison helped in examiningbaseline blood values and differences in pathways between normal andoverweight/obese. Then following the 90 days of being on the program,changes in their gene expression from baseline and the direction orsimilarities to a group of subjects that were not overweight or obesecould be compared.

Participants and Body Composition

There were 73 subjects that were screened to participate in the study.Seventy two subjects were randomized to participate. There were 69subjects (Females n=47; Males n=22) that completed day 14 and 66(Females n=45; Males n=21) that completed 90 days of the study (seeTable 4). The average age of the subjects were 43.8 years of age with anaverage baseline BMI of 31.1.

The products were well tolerated and the compliance of consuming theproducts were 96% overall with 96% and 94% for women and men,respectively.

TABLE 4 Number of subjects, average age, and body mass index (BMI)Subjects (n) Enrolled and Subjects (n) completed 14 Completed 90 daysdays Age (years)* Baseline BMI* Females 47 45* 44.1 ± 1.4 31.1 ± 0.5Males 22 21* 43.2 ± 1.3 31.2 ± 0.8 Total 69 66  43.8 ± 1.2 31.1 ± 0.5*means ± SEMThe reasons for subjects dropping from the study were:1. Voluntarily withdrew n=62. Non-compliance (not consuming the products) n=1There was a dramatic loss of body fat (day 90) and a maintenance of fatfree-mass (see Table 5).

TABLE 5 Changes in body fat, % body fat, fat-free mass, and body weight(Means ± SEM). Change Change in Change in Change in Change in Change inChange in in Body % Body % Body Fat Free Fat Free Body Body Fat (lbs)Fat Fat Mass (lbs) Mass (lbs) Weight (lbs) Weight (lbs) Day 1-90 Day0-14 Day 0-90 Day 0-14 Day 0-90 Day 0-14 Day 0-90 Females −12.9 ± 1.9−1.3% −6.0% +0.6 ± 0.7 +6.6 ± 1.0 −3.4 ± 0.4 −6.4 ± 1.3 Males −19.7 ±2.0 −1.6% −8.5% −0.5 ± 0.8 +7.5 ± 0.9 −5.4 ± 0.7 −12.1 ± 2.2  Total−15.1 ± 1.2 −1.4% −6.8% +0.2 ± 0.5 +7.0 ± 0.7 −3.8 ± 0.4 −8.2 ± 1.2Along with the changes in body composition there was a decline in BMIand an increase in basal metabolic rate as measured in a subset ofsubjects (see Table 6). There was some difficulty on the part of thestudy staff in obtaining accurate metabolic rates and for subjects thathad values that were not physiologically possible their RMR values wereremoved from the analysis. Respiratory quotient (RQ=C02 eliminated/0 2retained) a measure of substrate (carbohydrate vs fat) utilization onlychanged modestly.

TABLE 6 Changes in BMI, resting metabolic rates, and R-values (means ±SEM). Change in Change in Change Change Resting Resting Respiratory inBMI in BMI Metabolic Metabolic Quotient Day Day Rate (Kcals) Rate(Kcals) (change) 0-14 0-90 Day 0-14* Day 0-90* Day 0-90* Females −0.5 ±0.1 −1.1 ± −33.7 ± 33.6 +150.3 ± 0.85 0.2 35.7   (0.13 ± 0.01) Males−0.8 ± 0.1 −1.8 ± +13.8 ± 51.5 +116.6 ± 0.85 0.3 75.5 (−0.03 ± 0.02)Total −0.6 ± 0.1 −1.3 ± −15.9 ± 28.2 +147.1 ± 0.85 0.2 34.4 (−0.01 ±0.01) *A subset of subjects were included because there were severalsubjects that had RMR below 1,000 kcals at baseline. Therefore anysubject with a RMR below 1,000 was excluded, total n = 50, females n =33, males n = 17.

Body Measurements

Noticeable changes in body measurements and circumferences (waist, hip,arm and ankle) were noted (see Table 7). There were measurable changesthat occurred by day 14.

TABLE 7 Changes in body measurements (means ± SEM). Change in Change inChange in Change in Change in Change in Change in Change in WaistCircum- Waist Circum- Waist Circum- Hip Circum- Arm Circum- Arm Circum-Ankle Circum- Ankle Circum- ference (cm) ference (cm) ference (cm)ference (cm) ference (cm) ference (cm) ference (cm) ference (cm) Day0-14 Day 0-90 Day 0-14 Day 0-90 Day 0-14 Day 0-90 Day 0-14 Day 0-90Females −2.2 ± 0.5 −7.4 ± 0.9 −1.9 ± 0.4 −6.4 ± 0.7 −0.9 ± 0.3 −2.3 ±0.3 −0.7 ± 0.1 −1.6 ± 0.2 Males −1.8 ± 0.8 −7.9 ± 1.2 −0.9 ± 0.5 −5.8 ±1.2 −0.5 ± 0.3 −1.9 ± 0.3 −0.6 ± 0.2 −1.0 ± .03 Total −2.1 ± 0.4 −7.4 ±0.7 −1.5 ± 0.3 −6.1 ± 0.6 −0.8 ± 0.2 −2.2 ± 0.3 −0.7 ± 0.1 −1.4 ± 0.3

Labs and Safety

In determining safety, blood chemistries and complete counts weremeasured at baseline and at day 90 (see Table 8). These values were allwithin the normal range except for LDL cholesterol and ALT. The LDL didnot change from baseline and the study physician noted that the higherlevels of LDL were not clinically significant. Regarding the ALT, therewas one female subject that had elevated ALT at Day 90 which caused theaverage to be slightly above the normal range. The study physician notedthat this level of ALT was not clinically significant. If this subjectis not included in the averages, the ALT level was 35.6 U/L.

TABLE 8 Blood chemistries and complete blood cell count of subjects atbaseline and day 90 (means ± SEM). Total Females Males Baseline 90 DayBaseline 90 Day Baseline 90 Day Reference Ranges Sodium (mmol/L) 138.4 ±0.2  138.8 ± 0.2  138.6 ± 0.2  138.6 ± 0.3  138.0 ± 0.2  139.3 ± 0.4 136-140 Potassium (mmol/L)  4.0 ± 0.04  4.2 ± 0.04  4.0 ± 0.05  4.1 ±0.05  4.2 ± 0.1  4.2 ± 0.1 3.5-5.1 Chloride (mmol/L) 105.0 ± 0.3  104.2± 0.2  105.5 ± 0.3  104.4 ± 0.2  104.1 ± 0.7  103.8 ± 0.4  3.5-5.1 UreaNitrogen 13.4 ± 0.5 14.0 ± 0.5 12.6 ± 0.6 13.4 ± 0.6 15.3 ± 0.8 15.7 ±0.8  8-26 (BUN/Urea) Glucose (mg/dL) 87.4 ± 1.2 88.6 ± 1.1 85.9 ± 1.587.6 ± 1.3 90.7 ± 1.3 90.7 ± 1.9  96-109 Hematocrit (%) 43.2 ± 0.3 42.9± 0.5 42.5 ± 0.6 41.3 ± 0.6 48.8 ± 0.9 45.7 ± 0.7 Females 34.7-50.0Males 36-50 Hemoglobin (g/dL) 14.8 ± 0.2 14.4 ± 0.2 14.4 ± 0.2 13.8 ±0.2 15.7 ± 0.3 15.5 ± 0.1 Females 12.1-17.1 Males 12-18 Prothrombin time10.8 ± 0.1 11.0 ± 0.1 10.6 ± 0.1 10.9 ± 0.1 11.2 ± 0.2 11.1 ± 0.1 9.7-13.3 (Seconds) Aspartate 22.0 ± 1.0 29.2 ± 7.8 21.7 ± 1.2 32.5* ±11.6 23.4 ± 1.1 22.7 ± 1.1 15-37 aminotransferase AST (U/L) Alaninetransaminase 24.6 ± 1.7  58.4 ± 20.4 22.8 ± 2.0 65.8* ± 30.2 27.9 ± 2.942.6 ± 1.7 30-65 ALT (U/L) Cholesterol (mh/dL) 183.7 ± 3.9  187.4 ± 4.5 185.8 ± 3.9  185.8 ± 5.1  179.6 ± 9.0  190.8 ± 9.3  <200 LDL (mg/dL)111.1 ± 3.3  118.4 ± 3.6  11.7 ± 3.2 115.8 ± 4.0  108.9 ± 8.1  122.4 ±7.5  <100 HDL (mg/dL) 50.4 ± 1.5 50.2 ± 1.3 45.3 ± 2.2 52.2 ± 1.7 45.0 ±1.7 48.0 ± 1.2 38-50 Cholesterol/HDL  3.8 ± 0.1  3.9 ± 0.1  3.7 ± 0.1 3.7 ± 0.1  4.0 ± 0.2  4.1 ± 0.2 Triglycerides (mg/dL) 114.2 ± 6.6  88.8± 5.4 107.2 ± 7.1  84.0 ± 6.6 133.8 ± 13.9 100.9 ± 9.2  <150 White BloodCell Count  635 ± 0.2  6.2 ± 0.2  6.7 ± 0.3  6.3 ± 0.3  6.3 ± 0.3  6.0 ±0.3 4.5-11  (1000/mm3) Red Blood Cell Count  4.8 ± 0.1  4.7 ± 0.1  4.6 ±0.0  4.6 ± 0.1  5.1 ± 0.1  5.1 ± 0.1 4.3-5.8 (million/mcl) Meancorpuscular 90.3 ± 0.8 87.9 ± 0.4 90.4 ± 1.1 87.4 ± 2.0 90.1 ± 0.8 85.6± 0.9  84-100 volume—MCV (fl) Mean corpuscular 30.2 ± 0.3 29.9 ± 0.330.1 ± 0.3 29.9 ± 0.5 30.3 ± 0.3 30.0 ± 0.4 27.5-33.5 hemoglobin—MCH(pg) Mean corpuscular 33.4 ± 0.3 33.6 ± 0.1 33.3 ± 0.2 33.5 ± 0.1 33.7 ±0.2 33.7 ± 0.2 31-37 hemoglobin concentration—MCHC (gm/dL) Mean platelet 8.8 ± 0.1  9.2 ± 0.1  8.9 ± 0.1  9.3 ± 0.1  8.5 ± 0.9  8.8 ± 0.2 7.4-10.4 volume—MPV (fl) Red blood cell  1.1 ± 0.2 13.8 ± 0.2 14.3 ±0.2 14.0 ± 0.3 13.8 ± 0.3 13.5 ± 0.2 11.6-15.5 distribution width—RDW(%)Platelet count—PLT 258.6 ± 4.4  248.0 ± 6.7  266.5 ± 7.2  252.1 ± 7.5 244.5 ± 12.1 243.2 ± 13.8 140-440 (1000/cm3) Segs (%) 62.0 ± 1.0 59.9 ±2.2 62.9 ± 1.0 59.8 ± 2.0 60.4 ± 2.4 59.5 ± 5.7 44.0-80.0 Lymphocytes(%) 29.0 ± 0.3 30.2 ± 1.3 28.4 ± 0.9 30.6 ± 1.4 30.1 ± 1.1 29.9 ± 2.910.0-42.8 Monocytes (%)  6.9 ± 0.2  6.6 ± 0.3  6.3 ± 0.2  6.5 ± 0.3  7.9± 0.3  6.9 ± 0.8  2.7-13.0 Eosinophils (%)  2.2 ± 0.2  2.2 ± 0.2  1.8 ±0.1  2.0 ± 0.2  2.9 ± 0.5  2.7 ± 0.5 0.0-8.1 Basophils (%)  0.6 ± 0.0 1.0 ± 0.1  0.5 ± 0.1  1.1 ± 0.2  0.6 ± 0.0  1.0 ± 0.2 0.0-1.4 *Onefemale subject had AST of 528 U/L and ALT of 362 U/L at day 90.Physician indicated that these were not clinically significant. Theother enzymes in each group were within the normal ranges.

There was little difference between baseline and day 90 for systolic anddiastolic blood pressures, pulse rate, respirations, and bodytemperature (see Table 9).

TABLE 9 Vital Signs (average ± SEM) Total Females Males Baseline 90 DayBaseline 90 Day Baseline 90 Day Systolic Blood 125.7 ± 1.2  123.2 ± 1.3 123.2 ± 1.6  121.1 ± 1.3  128.8 ± 1.7  127.7 ± 2.6  Pressure (mmHG)Diastolic Blood 79.2 ± 0.7 77.8 ± 0.9 78.8 ± 0.8 78.2 ± 1.0 79.7 ± 1.477.6 ± 1.7 Pressure (mmHg) Pulse rate 69.9 ± 1.5 68.7 ± 1.2 71.6 ± 1.769.9 ± 1.3 66.6 ± 2.7 66.0 ± 2.5 (beats/min) Respiration 14.9 ± 0.2 15.5± 0.2 14.9 ± 0.3 15.5 ± 0.2 15.0 ± 0.3 15.5 ± 0.2 (breaths/minute) Bodytemperature 97.2 ± 0.1 97.0 ± 0.1 97.3 ± 0.1 97.0 ± 0.1 97.1 ± 0.1 97.0± 0.2 (° F.)

There was an increase in biophotonic scanner score and by using digitalpulse wave analyzer the estimated biological age was lower thanchronological age at baseline and dropped slightly, particularly for thefemales at day 90 (see Table 10).

TABLE 10 Biophotonic Scanner Scores at baseline and day 90 (means ± SEM)along with the chronological ages and estimated biological ages.Biophotonic Biophotonic Chronological *Estimated Estimated Scanner ScoreScanner Score Age of Subjects Biological Biological Age (Raman Units)(Raman Units) at baseline Age at Baseline at day 90 Baseline Day 90(Years) (Years) (Years) Females 24,694 ± 1,284 29,987 ± 1,480 44.1 ± 1.436.9 ± 1.6 36.5 ± 1.7 Males 27,380 ± 1,940 29,943 ± 2,080 43.2 ± 1.334.4 ± 1.9 34.8 ± 1.0 Total 25,351 ± 1,070 29,936 ± 1,198 43.8 ± 1.236.0 ± 1.3 35.4 ± 1.0 *Based on vascular stiffnessThere were no Serious Adverse Events Reports. There was a total of 10adverse events report by 6 subjects. Table 11 lists all the relatedadverse events as probably or possibly related to the products.

TABLE 11 Listing of adverse events probably or possibly related to theproducts (total of 6 subjects reported adverse events, 6/73-8.2% ofsubjects). Number of Episodes Gastrointestinal Related Upset stomach 2Nausea 2 Vomiting 1 Constipation 1 Diarrhea 1 Abdominal cramps 1 OtherHeadache 1 Insomnia 1

Questionnaires

Subjects were given questionnaires regarding overall satisfaction withthe program, if they had tried other weight loss programs they wereasked to respond how the tested system compared. They were also askedwhether they could notice a change in their silhouette at 2 weeks and atday 90.

Furthermore, they were asked if they noticed their clothing fittingdifferently or if the program was helping them lose weight. Lastly, aquestionnaire regarding the subjects' quality of life was administeredbut the data is still being evaluated and will be included at a laterdate.

Self-Reported Questionnaires: After 2 Weeks on Program

-   -   1) 83% of subjects had an overall positive satisfaction with the        program    -   2) 96% of Subjects said this program is better or extremely        better than other programs they have tried (81% of participants        had been on other programs).        In addition, 85% of subjects notice a change in body silhouette,        98% indicated that their clothes fit differently, and 91%        indicated that the program was helping them to lose weight.

Report after 12 Weeks of Program Participation

-   -   1) 73% of subjects had an overall positive satisfaction with the        program    -   2) 87% of Subjects said this program is better or extremely        better than other programs they have tried (81% of participants        had been on other programs).        In addition, 92% of subjects notice a change in body silhouette,        94% indicated that their clothes fit differently, and 89%        indicated that the program was helping them to lose weight.

Discussion

Eighty percent of participants lost weight (Females, n=32 and Males,n=21) while a few subjects maintained or gained weight (Females, n=13and Males, n=O). Interestingly, there was a dramatic loss of body fat(approximately 20 pounds and 13 pounds for females and males,respectively) and maintenance of fat-free body mass (approximately 7pounds). These effects were seen both in the females and males. Thestudy found similar results to another study which noted a loss of fatand maintenance of fat-free mass by providing approximately 1.6 gprotein/kg body weight. These effects are attributed to the system,since there were no controls for diet or supplements alone. The studyfindings support the program of losing primarily fat and maintainingloss of fat-free mass during restricting energy.

It is important to recognize that weight management is not simply aboutreduction in body weight. It is advantageous to maintain lean tissue(muscle), in that it lean tissue has a higher metabolic rate.

Many weight loss programs note 20-40% of the weight as fat-free masslost simply because the body meets its energy demands from muscle orfat. Particularly when carbohydrates are consumed it signals the body,via insulin, to shift from releasing to storing free fatty acids. Thisleads to energy demands being met by protein. The strategy in this studywas to provide adequate amount of protein (2 portions of proteinproviding at least 30 grams of protein) at each meal to signal the bodyto maintain muscle and meet energy demands via fat. The finding that themajority of weight being lost was primarily fat is an important finding.This finding that body composition changes are occurring is supported bythe changes in body measurements (i.e. waist, hip, arm, calf, and anklecircumference).

This was also supported by the response of the subjects to thequestionnaire that they were noting changes in their silhouette as welltheir clothing fitting differently. Furthermore, the subjects noted orobserved changes within the first 14 days of the program.

The products and program were well accepted and there was a low dropoutrate from the study as well as very few adverse events noted. It wasanticipated that the ingredients selected were safe and this studyconfirms very little change in labs (metabolic and lipid profiles) andcomplete blood cell count as well as vital signs did not change;indicating that the products and program are safe.

Based on self-reported questionnaires, the subjects indicated that theprogram assisted in weight loss and a majority of subjects that had usedweight loss programs or products indicated that this program was betterthan other programs.

The Biophotonic Scanner scores increased slightly over the course of thestudy. This appears to be the change in dietary habits and increasedconsumption of carotenoid containing foods (fruits and vegetables) inthat the subjects could not consume dietary supplements which can alsobe a source of carotenoids.

It was interesting that the resting metabolic rate increased but the RQvalues did not change much. An RQ value of 1.00 would indicate theutilization of carbohydrates while an RQ value of 0.7 would indicate theutilization of fat to meet energy demands. There is complexity indetermining RQ of utilizing proteins or amino acids but since thefat-free mass did not change (actually increased slightly over thecourse of the study) no conclusion can be made regarding the RQ valuesand maintenance of lean tissue. Overall, the subject were utilizing amixture of carbohydrates and fats (RQ of 0.85) to meet their energydemands. This may have also indicated that the subjects were in a fastedstate and made it difficult to see any shifts in the respiratoryquotient, even though the subjects appear to be utilizing primarily fat.

By using the digital pulse wave analyzer, it was possible to measure thearterial wall elasticity or stiffness and estimate the biologicalarterial age. There was a slight overall improvement, which wasprimarily from improvement in the females with weight loss. However, itis interesting that the biological age estimation was significantlylower at baseline as compared to the chronological age by approximatelysix years. This may indicate that the population included in the studywere healthy other than being overweight or obese.

While the forgoing examples are illustrative of the specific embodimentsin one or more particular applications, it will be apparent to those ofordinary skill in the art that numerous modifications in form, usage anddetails of implementation can be made without departing from theprinciples and concepts articulated herein. Accordingly, no limitationis intended except as by the claims set forth below.

What is claimed is:
 1. A weight loss system comprising: a weight loss accelerator formulation that accelerates weight loss in a subject beginning to utilize the system; a weight loss stimulator formulation that stimulates weight loss in a subject beginning to utilize the system and continues stimulating weight loss with ongoing consumption after completing use of the weight loss accelerator; and a weight loss control formulation that aids a subject in controlling appetite and calorie consumption when said subject is beginning and continuing to utilize the system.
 2. The system of claim 1, wherein the weight loss accelerator formulation is administered at least once daily for up to 30 days from the time a user begins using the system.
 3. The system of claim 2, wherein the weight loss accelerator formulation is administered once daily for a duration of 15 days from the time a user begins using the system.
 4. The system of claim 1, wherein the weight loss accelerator is administered as a beverage.
 5. The system of claim 4, wherein the beverage is prepared from a powder.
 6. The system of claim 1, wherein the weight loss accelerator formulation provides a dosage comprising from about 1000 mg to about 3000 mg opuntia ficus-indicia (prickly pear) fruit powder; from about 100 mg to about 200 mg crocus sativus L. stigma (saffron) fruit powder extract; from about 100 mg to about 200 mg punica granatum (pomegranate) fruit extract; and from about 100 to about 200 mg of citrus sinensis (blood orange) fruit extract.
 7. The system of claim 5, wherein the amount of opuntia ficus-indicia is about 2000 mg; the amount of crocus sativus L. stigma is about 177 mg; the amount of punica granatum is about 150 mg; and the amount of citrus sinensis is about 125 mg.
 8. The system of claim 1, wherein the weight loss stimulator formulation is administered at least once daily for up to 360 days from the time a user begins using the system.
 9. The system of claim 8, wherein the weight loss stimulator formulation is administered daily for up to 90 days from the time a user begins using the system.
 10. The system of claim 9, wherein the weight loss stimulator formulation is administered to the subject within 30 minutes of eating each meal.
 11. The system of claim 1, wherein the weight loss stimulator formulation is in an oral dosage capsule form.
 12. The system of claim 1, wherein the weight loss stimulator formulation provides a dosage comprising a citrus sinensis (red orange) fruit extract in amount of from about 50 mg to about 250 mg; a undaria pinnatifida (brown seaweed) extract in an amount of from about 50 to about 250 mg; a camellia sinensis (green tea) leaf extract in an amount of about 30 to about 150 mg; citrus bioflavonoids in an amount of from about 20 mg to about 100 mg; quercetin (an allium cepa alliaceae (onion) bulb extract) in an amount of from about 10 mg to about 75 mg; and a capsicum annum L. (cayenne) fruit powder in an amount of from about 10 mg to about 52 mg.
 13. The system of claim 12, wherein the amount of citrus sinensis fruit extract is about 83.3 mg; the amount of undaria pinnatifida extract is about 83.3 mg; the amount of camellia sinensis leaf extract is about 50 mg; the amount of citrus bioflavonoids is about 33.3 mg; the amount of quercetin is about 25 mg; and the amount of capsicum annum L. fruit powder is about 16.7 mg in an individual unit dosage.
 14. The system of claim 13, wherein three individual unit dosage forms are administered daily.
 15. The system of claim 1, wherein the weight loss control formulation is administered at least once daily for up to 360 days from the time a user begins using the system.
 16. The system of claim 15, wherein the weight loss control formulation is administered daily for up to 90 days from the time a user begins using the system.
 17. The system of claim 1, wherein the weight loss control formulation provides a dosage comprising a theobroma cacao (cocoa) bean powder extract in an amount of from about 150 mg to about 1500 mg; a prunus cersus (tart cherry) fruit powder extract in an amount of from about 75 mg to about 600 mg; a punica granatum (pomegranate) fruit extract in an amount of from about 60 mg to about 500 mg; and a camellia sinensis (green tea) leaf extract with added L-theanine in an amount of from about 100 mg to about 860 mg.
 18. The system of claim 17, wherein the amount of theobroma cacao extract is about 187.5 mg; the amount of prunus cersus extract is about 75 mg; the amount of punica granatum extract is about 62.5 mg; and the amount of camellia sinensis extract is about 107.5 mg in an individual dosage unit.
 19. The system of claim 18, wherein four individual unit dosage forms are administered daily.
 20. The system of claim 19, wherein two individual unit dosage forms are administered prior to two meals.
 21. The system of claim 20, wherein the administration is within 30 minutes prior to the meals.
 22. The system of claim 1, further comprising a protein supplement that can be consumed by the subject as needed to maintain a minimum daily protein intake.
 23. The system of claim 22, wherein the protein supplement provides at least 30 grams of protein.
 24. A weight loss system comprising: a weight loss accelerator formulation that accelerates weight loss in a subject beginning to utilize the system, said accelerator formulation providing a dosage comprising about 2000 mg opuntia ficus-indicia (prickly pear) fruit powder, about 177 mg crocus sativus L. stigma (saffron) fruit powder extract, about 150 mg punica granatum (pomegranate) fruit extract, and about 125 mg of citrus sinensis (blood orange) fruit extract; a weight loss stimulator formulation that stimulates weight loss in a subject beginning to utilize the system and continues stimulating weight loss with ongoing consumption after completing use of the weight loss accelerator, said stimulator formulation providing a dosage comprising about 83.3 mg of a citrus sinensis (red orange) fruit extract, about 83.3 mg of a undaria pinnatifida (brown seaweed) extract, about 50 mg of a camellia sinensis (green tea) leaf extract, about 33.3 mg of citrus bioflavonoids, about 25 mg of quercetin (an allium cepa alliaceae (onion) bulb extract), and about 16.7 mg capsicum annum L. (cayenne) fruit powder; and a weight loss control formulation that aids a subject in controlling appetite and calorie consumption when said subject is beginning and continuing to utilize the system, said weight loss control formulation provides a dosage comprising about 187.5 mg theobroma cacao (cocoa) bean powder extract, about 75 mg of a prunus cersus (tart cherry) fruit powder extract, about 62.5 mg of a punica granatum (pomegranate) fruit extract, and about 107.5 mg of a camellia sinensis (green tea) leaf extract with added L-theanine wherein one unit dosage of the weight loss accelerator formulation is administered once daily for a duration of about 15 days from the time that a user commences the program and three unit dosages of the weight loss stimulator are individually administered once daily for a duration of about 90 days from the time that a user commences the program, and two unit dosages of the weight loss control formulation are administered twice daily.
 25. A weight loss regimen comprising: administering a weight loss accelerator formulation to a subject at the beginning of the regimen; administering a weight loss stimulator formulation to the subject at the beginning of the regimen concurrently with the weight loss accelerator formulation and continuing after cessation of the weight loss accelerator formulation; and administering a weight loss control formulation to the subject concurrently with the weight loss stimulator formulation.
 26. The regimen of claim 25, further comprising administering to the subject a protein supplement concurrently with all previously recited weight loss formulations in order to maintain a minimum daily protein intake.
 27. The regimen of claim 25, wherein the weight loss accelerator is administered to the subject for a period of 15 days at the beginning of the regimen;
 28. The regimen of claim 25, wherein the weight loss stimulator and control formulations are administered to the subject for a period of 90 days.
 29. The regimen of claim 25, further comprising an eating plan that delivers 6 portions of protein, 2 portions of vegetables, 2 portions of fruit, and 2 portions of complex carbohydrates per day.
 30. The regimen of claim 29, wherein each portion has a size based on the subjects hand size and approximately one handful equals approximately one portion.
 31. A method of controlling weight in a subject comprising: engaging the subject in a weight loss regimen as recited in claim
 25. 32. A method of inducing weight loss in a subject while minimizing lean muscle tissue loss comprising administering a weight loss regimen as recited in claim 25 to the subject. 